Head of Quality & Regulatory Affairs

TEC Partners are pleased to be recruiting a Head of Quality & Regulatory Affairs for a high-growth digital in-vitro diagnostics start-up to join their expanding team following a recent round of successful funding. Aiming to improve global health through a digital platform allowing easy and immediate blood testing, health assessment and follow-on care to implement lasting change within the medical device sector. Your responsibility as the Head of Quality & Regulatory Affairs will be to help take the product from Clinical to Commercial production on a global scale while working in a fast-paced, close-knit environment giving guidance to senior and junior members of staff.

Head of Quality & Regulatory Affairs Role:

• Quality assurance of Medical Devices to ISO 13485 standards, as well as ensuring company procedures and processes align to ISO 13485 and 21 CFR Part 820
• Responsible for product release to the market
• Responsible for the IVDR directive
• Providing support and training to staff in operation of quality assurance and control methods
• Ensure effective coordination and implementation of regulatory activities in support of product development, registration and life cycle maintenance
• Manage regulatory agency and submissions ensuring compliance for the development of new products

Head of Quality & Regulatory Affairs Requirements

• Minimum of 5 years' experience with an IVD manufacturer
• Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
• Experience conducting internal audits and hosting external audits
• Demonstrate a clear understanding of ISO 13485:2016 and the detectives for CE marking
• Experience with Medical Device Software Development is beneficial

As an integral part of the business aiding my client's product to hit the market this years, you will be rewarded with competitive salary options, private health insurance and life insurance.

If this opportunity is of interest, please apply with an up to date CV.